Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors
Information
Type
Information Sheet
Regulated products
Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE)
Published
January 1, 2006
Last updated
August 10, 2023
Description
This document provides guidance on conducting medical device studies, covering topics like GCP and IDE, for IRBs, investigators, and sponsors.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)